MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-08 for TRANSMOTION MEDICAL INC TMM4-XWB manufactured by Transmotion Medical Inc..
[15351868]
Customer notified that two of their chairs were moving on their own due to a faulty pendant. No pt info was provided as it was a general concern. No adverse event occurred.
Patient Sequence No: 1, Text Type: D, B5
[15641387]
The immediate action taken was to replace older style pendants with newly designed pendants for all devices in the facility. There was not an adverse event. It was mentioned that there would be patients on the device. It was presented to tmm as a general concern, not specifically related to any one pt. Transmotion medical inc has designed a new pendant which was released in 05/2013. The new pendant is considerably more durable than the older style pendants. The new pendant has been in production for 17 months and there have been no reports of the new pendant cause the device to move on its own. Additionally, in 11/2014, transmotion medical inc launched a product recall due to previous customer complaint and corresponding mdr data. This mdr is for voluntary reporting purposes only.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082462-2014-00004 |
| MDR Report Key | 4417561 |
| Report Source | 06 |
| Date Received | 2015-01-08 |
| Date of Report | 2015-01-08 |
| Date of Event | 2014-12-09 |
| Date Mfgr Received | 2014-12-09 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2015-02-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1441 WOLF CREEK TRAIL |
| Manufacturer City | SHARON CENTER OH 44274 |
| Manufacturer Country | US |
| Manufacturer Postal | 44274 |
| Manufacturer Phone | 3302394192 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSMOTION MEDICAL INC |
| Generic Name | TMM4 MULTIO-PURPOSE STRETCHER-CHAIR |
| Product Code | GBB |
| Date Received | 2015-01-08 |
| Model Number | TMM4-XWB |
| Catalog Number | TMM4-XWB |
| Lot Number | 5379-5380 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRANSMOTION MEDICAL INC. |
| Manufacturer Address | 1441 WOLF CREEK TRAIL SHARON CENTER OH 44274 US 44274 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-08 |